Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03659266 |
| Other study ID # |
2017-69 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2019 |
| Est. completion date |
December 7, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in
the paretic lower limb frequently causes these walking disabilities, and the gold standard
treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks
following injection, but the protocols vary and few have been evaluated in the medical
literature.
In particular, the effect on walking ability of combined treatment by botulinum toxin A and
robot-assisted gait training has never been evaluated.
Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates
botulinum toxin's effects better than conventional walking therapy.
The aim of this study was to evaluate the effects on walking ability of the association of
focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in
patients suffering from spastic hemiparesia after stroke in the chronic phase.
Outcome:
-Primary: distance walked (meters) in the six-minute walk test (SMWT)
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have
already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
Following a preliminary study which had the six-minute walk test as a secondary outcome, the
expected results are a significant improvement of the distance walked in the SMWT after
robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin
injections, and to justify the use of robotic rehabilitation for patients in the chronic
phase of stroke.
Description:
Introduction :
75% patients in the chronic phase of a stroke (>6 months) keep walking disabilities. Focal
spasticity in the paretic lower limb frequently causes these walking disabilities, and the
gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic
muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks
following injection, but the protocols vary and few have been evaluated in the medical
literature.
In particular, the effect on walking ability of combined treatment by botulinum toxin A and
robot-assisted gait training has never been evaluated.
Materials and Methods:
Tested hypothesis:
Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's
effects better than conventional walking therapy.
Aims:
- Primary: to evaluate the effects on walking ability of the association of focal
spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in
patients suffering from spastic hemiparesia after stroke in the chronic phase.
- Secondary: to determine the optimal time between the toxin injection and the start of
robotic rehabilitation; to evaluate the effects of the combined treatment on the balance
and spasticity.
Outcome:
- Primary: distance walked (meters) in the six-minute walk test (SMWT)
- Secondary: walking speed (meters/seconds), balance (Timed Up and Go Test, Berg Balance
Scale), spasticity (score on the Modified Ashworth Scale and joint range of motion)
Study Design:
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have
already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
1. st Group D0: Injection of Botulinum toxin A in triceps surae, according to
pre-established modalities (no influence of the experimental protocol on this stage)
W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation
department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8:
Conventional walking rehabilitation in the functional rehabilitation department
(conventional hospitalization)
2. nd Group: D0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional
walking rehabilitation in the functional rehabilitation department (conventional
hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking
rehabilitation by Lokomat® in the functional rehabilitation department (conventional
hospitalization)
Expected results:
Following a preliminary study which had the six-minute walk test as a secondary outcome, the
expected results are a significant improvement of the distance walked in the SMWT after
robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin
injections, and to justify the use of robotic rehabilitation for patients in the chronic
phase of stroke.
